Regulators Who? | The Rise in Medical Spa Regulation

Wednesday, January 18, 2017

By: Alex Thiersch

In recent years, the medical aesthetics industry has experienced explosive growth. According to the American Society for Aesthetic Plastic Surgery (ASAPS), consumers spent more than $13.87 billion on aesthetic procedures in 2015—an all-time high. 😳

These numbers are certainly good news for you; however, such robust growth and visible success has caused regulators on both the state and federal levels to begin taking a closer look at the industry. What these regulators are finding are areas in which legalities are poorly defined, enforcement is lax, and punishment is viewed as insufficient. State regulatory agencies have traditionally been underfunded and undermanned, but they are beginning to take action to rectify these perceived oversights.

This increased scrutiny could potentially be very bad news for owners and operators of your medical aesthetics practice, if you are non-compliant. Laws are changing, enforcement is increasing, and punishments are becoming more severe. Take the time to review this guide to learn about the areas in which regulators are beginning to crack down and correct any shortcomings your practice may have as soon as possible!

A CASE IN POINT

The case of microneedling is an example of the ways in which regulations are evolving. Microneedling—also known as collagen induction therapy (CIT)—is a skin treatment in which small needles penetrate the skin in order to create superficial wounds that stimulate the production of collagen and other growth factors. It produces visible results with little chance of complications, and it has become popular with both patients and professionals because it is simple, fast, and lucrative.

However, microneedling is not without controversy. The primary issue surrounding this procedure revolves around whether or not it is medical in nature. Typically, any treatment that breaks the outer layer of the patient’s skin is considered to be medical. It stands to reason that any procedure involving a needle also involves breaking the skin, but determining whether or not the skin is actually being broken is very difficult when you are dealing with tiny needles that can be only fractions of a millimeter long. Other factors that affect this judgment include the part of the body being treated and the amount of pressure being applied.

Because these distinctions are typically not codified in state rules and regulations, you might have allowed these procedures to be performed by unlicensed personnel, such as aestheticians, and have administered these treatments without a physician first conducting an exam, as is required prior to a medical procedure. Although these shortcuts might have allowed you to see more patients and use licensed medical professionals less often, it is not recommended to continue ignoring.

For instance, in recent months, regulatory bodies in both California and Illinois have asserted that microneedling is an invasive procedure and, thus, medical in nature, regardless of depth. According to these agencies, aestheticians are absolutely prohibited from administering this treatment, and a face-to-face exam by a physician or mid-level practitioner is always required prior to the procedure. This proves that regulators have their eyes on this issue and, as these two states go, it is likely that so too will go much of the industry. Because of this, this former grey area may quickly become much more black and white.

Another example is Colorado, in which the state medical board is in the process of reviewing its regulations to more clearly specify which procedures should be viewed as medical and which should be viewed as non-medical. Notably, these revisions indicate that state regulators will take stricter views of certain treatments—the use of Class I lasers, for example, is designated non-medical, but the use of Class II and above lasers is classified as being medical in nature.

There are a number of these “in-between” types of procedures—laser treatments, dermaplaning, ultrasound and other body-sculpting treatments, for instance—that tend to be viewed with suspicion by state regulators. If an unconventional or new technology appears to them to be under-regulated, the state will likely err on the side of issuing sanctions, regardless of whether specific statutes actually govern the administration of these treatments. This trend indicates regulators will tend to view the majority of procedures offered by medical aesthetic facilities as medical in nature. Therefore, you should get used to the idea that you will need to provide initial physician exams (or exams by mid-levels) for more of your patients and that licensed medical professionals will need to perform many of these procedures. This will almost certainly take a bite out of the bottom lines of your medical aesthetic practices, as it costs more to employ medically licensed personnel to do work that was formerly performed by non-medically licensed individuals; however, if you wish to stay compliant, you will likely have no choice but to make this change.

If you are the owner or operator of a medical aesthetic practice, it can sometimes seem as though the deck is stacked against you. However, the key to avoiding the pitfalls described above is learning more about them. Consulting with a healthcare attorney is a good first step toward finding out what you need to do to keep your practice in the law’s good graces.

AmSpa provides a variety of legal and regulatory resources for medical aesthetic practices and medical spas to help you stay legal and compliant. Learn more about our member benefits here.